Department of Health and Human Services December 23, 2019 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request;
Document Number: 2019-27667
Type: Notice
Date: 2019-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-27583
Type: Notice
Date: 2019-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2019-27582
Type: Notice
Date: 2019-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27559
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for Tuberculosis Data from Referring Entities to CureTB, which enables CDC to coordinate continuity of care services for individuals with tuberculosis.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27557
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Airline and Vessel and Traveler Information Collection (42 CFR part 71) that enables CDC to order air carriers and maritime vessels to provide certain contact information for travelers in the event there is a confirmed illness onboard that poses a public health risk.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27556
Type: Notice
Date: 2019-12-23
Agency: Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``APPLETREE Performance Measures,'' which ATSDR will use to manage its next three-year cooperative agreement program under Notice of Funding Opportunity (NOFO) No. CDC-RFA-TS20-2001.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27555
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enterprise Laboratory Information Management System which is a system used to record specimen metadata and patient data related to test order requests submitted by external partners (state public health laboratories, International organizations, federal institutions, hospitals, doctor's offices, etc.) to the CDC Infectious Diseases testing laboratories.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27554
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Chronic Q Fever in the United States: Enhanced Clinical Surveillance.'' This enhanced medical surveillance for chronic Q fever will collect specific clinical data not otherwise collected during routine public health surveillance to allow for better characterization of the clinical presentation and risk factors of chronic Q fever in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-27553
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``2019 Lung Injury Response Understanding Vaping Practices In the United States.'' This is a formative study to identify why people are getting sick after vaping/ dabbing, in order to narrow the list of products, substances, and risk factors requiring further public health action.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-27551
Type: Notice
Date: 2019-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-27550
Type: Notice
Date: 2019-12-23
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2019-27475
Type: Notice
Date: 2019-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs.
Importation of Prescription Drugs
Document Number: 2019-27474
Type: Proposed Rule
Date: 2019-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. If the rule is finalized as proposed, States or certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity. The rule, when finalized, would contain all requirements necessary for a State or other non-federal governmental entity and its co-sponsors, if any, to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the proposed rule would require that the State or non-federal governmental entity and its co-sponsors, if any, explain why their program would be expected to result in a significant reduction in the cost of covered products to the American consumer.
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization
Document Number: 2019-27418
Type: Proposed Rule
Date: 2019-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the Organ Procurement Organization (OPO) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current measures with new transparent, reliable, and objective measures.
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